Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control

This study is currently recruiting participants.
Verified November 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs ( Philadelphia Veterans Affairs Medical Center )
ClinicalTrials.gov Identifier:
NCT01651117
First received: July 24, 2012
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to test the effectiveness of a peer mentor model in a mixed race population of poorly controlled diabetic veterans. Also, the study aims to assess the effects of becoming a mentor on those who originally were mentees. It is expected that participants in the peer mentoring arms (Arm 2 and 3) will have improved glucose control regardless of race or ethnicity at the end of the intervention.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Behavioral: Peer Mentoring
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control (CEPACT)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in Glucose Control [ Time Frame: Baseline, 6 months, and 12 months and for former mentees 18 months ] [ Designated as safety issue: No ]
    Measured by change in HbA1c


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: Baseline, 6 months, 12 months and for former mentees 18 months ] [ Designated as safety issue: No ]
  • Diabetes Quality of Life [ Time Frame: Baseline, 6 months, 12 months and for former mentees 18 months ] [ Designated as safety issue: No ]
    Diabetes Distress Scale

  • Depression Symptoms [ Time Frame: Baseline, 6 months, and 12 months and for former mentees 18 months ] [ Designated as safety issue: No ]
    As measured by the Patient Health Questionnaire-2

  • Direct LDL blood levels [ Time Frame: Baseline, 6 months, and 12 months and for former mentees 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: September 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Enrolled in two different time frames. No interventions will be provided to this arm. They will complete planned surveys, and blood draws (baseline, 6 months, and 12 months).
Experimental: Peer Mentoring
Participants in this arm will be mentored for 6 months by a veteran who was once in poor control but is now in good control. They will then be further randomized to either becoming a mentor for 6 months or having no other additional active intervention. All participants in this arm will be evaluated in person at baseline, 6 months, 12 months, and 18 months.
Behavioral: Peer Mentoring

Arm 2: Will receive peer mentoring from diabetic veterans who were once in poor control but are now in good control.

Arm 3: Will receive peer mentoring from former mentees.

Experimental: Peer Mentoring FFM (from former mentee)
Participants in this arm will be mentored by the former mentee for 6 months and will be followed in person for an additional 6 months after the completion of the active intervention.
Behavioral: Peer Mentoring

Arm 2: Will receive peer mentoring from diabetic veterans who were once in poor control but are now in good control.

Arm 3: Will receive peer mentoring from former mentees.


Detailed Description:

The primary objectives of this study are: (1) test the long-term effectiveness of a peer mentor model on improving glucose control, blood pressure, LDL levels, diabetes mellitus quality of life, and depression scores in a mixed race population of poorly controlled diabetic veterans; (2) test the effectiveness of using former peer mentees as peer mentors as a means of creating a self-sustaining program; and (3) and test the effects of becoming a mentor on those who were originally mentees given a growing literature that being a mentor is good for your health. Secondary objectives include: (1) in those randomized to being a mentee, explore mentor characteristics associated with improved HbA1c.

This study will be a prospective randomized controlled trial. Outcomes to be measured include glycosylated hemoglobin, blood pressure, direct LDL, diabetes quality of life and depression.

The trial has two phases. In phase one, patients with poorly controlled diabetes are randomized to usual care or receiving peer mentoring. In phase two, poorly controlled diabetics are randomized to usual care or receiving peer mentoring from former mentees. Former mentees from phase 1 are also randomized such that they will have a 50% chance of becoming a mentor.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All participants must have a diagnosis of Type 2 diabetics.
  • Diabetes began after age 30
  • Mentees: Have an HbA1c > 8% on 2 different occasions in the course of 24 months, with at least one measure within 3 months of enrollment
  • Mentors for Phase 1: Had an HbA1c of > 8% in the past 3 years and an HbA1c < (or equal to) 7.5% within 3 months of enrollment
  • Mentors for Phase 2: Former mentee

Exclusion Criteria:

  • Does not speak English
  • Unable to understand consents
  • Severe speech impediment
  • over the age of 75
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651117

Contacts
Contact: Kirsten M Rogers, BA 215-823-5800 ext 7929 Kirsten.Rogers3@va.gov
Contact: Jennifer Gutierrez, MS 215-823-5800 ext 7147 jennifer.gutierrez@va.gov

Locations
United States, Pennsylvania
Philadelphia Veterans Affairs Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kirsten M Rogers, BA    215-823-5800 ext 7929    Kirsten.Rogers3@va.gov   
Contact: Jennifer Gutierrez, MS    215-823-5800 ext 7417    jennifer.gutierrez@va.gov   
Principal Investigator: Judith A Long, MD         
Sponsors and Collaborators
Philadelphia Veterans Affairs Medical Center
Investigators
Principal Investigator: Judith A Long, MD Philadelphia Veterans Affairs Medical Center
  More Information

Publications:
Responsible Party: Department of Veterans Affairs ( Philadelphia Veterans Affairs Medical Center )
ClinicalTrials.gov Identifier: NCT01651117     History of Changes
Other Study ID Numbers: IIR 12-407, 01373
Study First Received: July 24, 2012
Last Updated: November 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Diabetes Mellitus
Mentors
Glucose control
Hemoglobin A, Glycosylated
Randomized Controlled Trial
Veterans

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014